FDA.reportPublic FDA data

NDC 0378-8263-16 - Methylphenidate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0378-8263
Requested NDC
0378-8263-16
Package NDCs from labels
0378-8263-16, 0378-8263-93
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2025-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylphenidate - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2025-10-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-8263-16Methylphenidate9 h in 1 PATCHPATCH96
0378-8263-16Methylphenidate1 in 1 POUCHPATCH16
0378-8263-93Methylphenidate30 in 1 CARTONPATCH306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8263METHYLPHENIDATE PATCH [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250330_1643b6a5-80da-4d4f-8c5f-feb907875702.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8263-16EA - Each0378-82638cb863ec-0c7d-4ad9-82df-1676dca37d6212022-07-06
0378-8263-93EA - Each0378-8263d6c8c8f0-b37f-4a95-bd0c-f498f9f18a9f12022-07-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 153 · 3,051 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
unii: F05Q2T2JA0
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
unii: F05Q2T2JA0
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
unii: F05Q2T2JA0
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
unii: F05Q2T2JA0
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Stool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESWALMART INC. (see also Equate)43fd4231-0962-4828-a3fa-a1faec81e43d2026-07-15WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
unii: F05Q2T2JA0
Laxative and Stool SoftenerDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)5be43e46-e49b-49eb-a95f-7c4577032f902026-07-13WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.